Featured Research

from universities, journals, and other organizations

Budget constraints limit FDA inspections, research finds

Date:
October 12, 2010
Source:
Inderscience Publishers
Summary:
Budgetary constraints are one of the principal factors that limit the US Food and Drug Administration's ability to conduct frequent and rigorous site inspections of pharmaceutical manufacturers, according to new research.

Budgetary constraints are one of the principal factors that limit the US Food & Drug Administration's ability to conduct frequent and rigorous site inspections of pharmaceutical manufacturers, according to research published in the International Journal of Business Continuity and Risk Management.

Related Articles


Warren Adis, Associate Professor of Information Sciences at the Hagan School of Business, Iona College, in New Rochelle, New York, has analyzed the FDA's risk methodology used for inspecting pharmaceutical manufacturing sites and reviewed its procedures, regulations, and violations as specified in the warning letters sent out by the Administration. The period on which Adis focused is 2004 to 2009, the time during which FDA was transitioning and formalizing its new approach to site inspections. The current research re-evaluates Adis' earlier study which compares the year 2005 when the new risk methodology was incorporated into the inspection process with the year 2008, to judge the impact of this new approach.

"A review of this composite period shows a more slowly declining using of warning letters and citations, with some leveling off in the last two to three years," explains Adis. "This current review therefore presents a more balanced evaluation of FDA performance." In his assessment, Adis suggests that budgetary constraints have led the FDA to use the inspection process as a policy tool to alert manufacturers on the necessity for installing quality risk-based systems, rather than a detailed analysis of manufacturer's violations.

"By failing to specify quality assurance violations, the FDA is not providing the necessary oversight and guidance to the pharmaceutical manufacturing industry," says Adis. Furthermore, by sustaining this less than rigorous approach, the FDA may be inadvertently allowing manufacturers to take advantage of the current system and to meet quality and standards obligations by building up complaints files and the like rather than addressing the actual safety and risk issues.

Adis has previously recommended that the FDA should use its risk methodology and its 820 regulations as tools to diagnose systemic weaknesses within a given manufacturer's production processes, and then provide detailed information that must be acted on. A more invigorated 820 inspection process will preclude manufacturers from the possibility of gaming the site inspections and improve safety across the industry and its products, says Adis.


Story Source:

The above story is based on materials provided by Inderscience Publishers. Note: Materials may be edited for content and length.


Journal Reference:

  1. Warren Adis. Assessing FDA's risk methodology at pharmaceutical manufacturing sites. International Journal of Business Continuity and Risk Management, 2010; 1 (3): 259 DOI: 10.1504/IJBCRM.2010.035689

Cite This Page:

Inderscience Publishers. "Budget constraints limit FDA inspections, research finds." ScienceDaily. ScienceDaily, 12 October 2010. <www.sciencedaily.com/releases/2010/10/101012095306.htm>.
Inderscience Publishers. (2010, October 12). Budget constraints limit FDA inspections, research finds. ScienceDaily. Retrieved November 28, 2014 from www.sciencedaily.com/releases/2010/10/101012095306.htm
Inderscience Publishers. "Budget constraints limit FDA inspections, research finds." ScienceDaily. www.sciencedaily.com/releases/2010/10/101012095306.htm (accessed November 28, 2014).

Share This


More From ScienceDaily



More Science & Society News

Friday, November 28, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola Leaves Orphans Alone in Sierra Leone

Ebola Leaves Orphans Alone in Sierra Leone

AFP (Nov. 27, 2014) The Ebola epidemic sweeping Sierra Leone is having a profound effect on the country's children, many of whom have been left without any family members to support them. Duration: 01:02 Video provided by AFP
Powered by NewsLook.com
EU Pushes Google For Worldwide Right To Be Forgotten

EU Pushes Google For Worldwide Right To Be Forgotten

Newsy (Nov. 27, 2014) Privacy regulators recommend Google expand its requested removals to apply to all its web domains. Video provided by Newsy
Powered by NewsLook.com
Who Will Failed Nuclear Talks Hurt Most?

Who Will Failed Nuclear Talks Hurt Most?

Reuters - Business Video Online (Nov. 25, 2014) With no immediate prospect of sanctions relief for Iran, and no solid progress in negotiations with the West over the country's nuclear programme, Ciara Lee asks why talks have still not produced results and what a resolution would mean for both parties. Video provided by Reuters
Powered by NewsLook.com
FCC Forces T-Mobile To Alert Customers Of Data Throttling

FCC Forces T-Mobile To Alert Customers Of Data Throttling

Newsy (Nov. 25, 2014) T-Mobile and the FCC have reached an agreement requiring the company to alert customers when it throttles their data speeds. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Science & Society

Business & Industry

Education & Learning

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins